Saloni Gupta

Results-driven QA/RA professional with 2+ years of experience in regulatory compliance, quality systems, and audit management within the medical device industry. Proven ability to manage CAPA, deviations, and regulatory documentation while ensuring adherence to global standards such as GMP and ISO. Adept at driving continuous improvement and supporting successful regulatory inspections.

Executive- RA at Biorad Medisys Pvt Ltd (2023-06 – Present)

Results-driven regulatory affairs professional managing regulatory compliance and submissions for medical devices across multiple countries.

• Write, analyze, and edit technical documents to support country-specific regulatory submissions and compile submissions in a format consistent with applicable guidance documents, including investigational device submissions in USA, Canada and Europe
• Work with other departments and communicate the submission requirements when documents are needed for regulatory submission
• Maintain regulatory files and update regulatory authorizations, such as IDEs, 510(k)s, Canadian medical device licenses, and CE dossiers for EU and other certifications
• Assure that appropriate maintenance of registrations occurs including renewals, device listings, site registrations, supplements for changes and annual reports
• Support approval in other regions as required
• Assist in preparing response to regulatory authorities questions within assigned timelines
• Handled deviations, CAPA, and change control processes
• Assess device related incidents/complaints for medical device reporting requirements
• Compile and submit reportable events to relevant regulatory authorities in timely manner
• Handle recalls and field actions, if required
• Conducted internal audits and supported external regulatory audits
• Performed risk assessments and implemented corrective actions
• Monitored and improved quality management systems (QMS)

Document Officer at KUMAR ORGANIC PRODUCTS LIMITED (2013-07 – 2017-07)

Technical professional handling microbial fermentation and upstream process development.

• Inoculum preparation
• Seed development in Shake flask
• Handling of Microbial fermentors 30L and 300L and CIP
• Upstream process development for broth
• Development and optimization of different feeding strategies in fermentor to get high cell density and productivity

Programme Development Manager at Ambedkar Institute Of Higher Education (2011-01 – 2012-03)

Project management professional overseeing programme development and planning initiatives.

• Programme Development and Planning of different projects pertaining to professional and technical courses
• Developing and maintaining a detailed project plan
• Managing co-ordination of the partners and working groups engaged in project work

Masters in Biotechnology – Bengaluru (2005-05 – 2007-08)